{"preliminary_commentary":{"by_channel":{"x_thread":7,"youtube":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02158988\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[],"indication":"gastric cancer with synchronous peritoneal metastases","name":"GASTRIPEC-I","nct_id":"NCT02158988","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gastripec-i-nct02158988. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"GASTRIPEC","arms":[{"description":"Preoperative chemotherapy 3 cycles, each cycle 21 days. Patients with negative or unknown HER-2 status receive Epirubicin 50 mg/m² infusion (maximum 100mg/d). Oxaliplatin 130 mg/m² infusion (maximum 260 mg/d) and capecitabine oral 625 mg/m² two times a day (maximum 2500 mg/d).\n\nPatients with positive HER-2 status receive:\n\nCisplatin : 80 mg/m² infusion (maximum of 160 mg/d). Capecitabine: oral 1000 mg/m2 (two times a day maximum of 4000 mg/d), on day 1-14.\n\nTrastuzumab: 8 mg/kg infusion (on cycle 1 and 6 mg/kg on cycle 2 and 3). CRS is performed and 4-12 weeks after CRS 3 cycles of postoperative chemotherapy have to be applied. In case of therapy failure patients will be continued to be treated by the responsible investigator according to his medical status.","label":"without HIPEC","type":"NO_INTERVENTION"},{"description":"Patients will be treated with a preoperative chemotherapy as described for the control group. EOX or CCT depending on the HER-2 status.\n\nCRS will be performed 2 to 3 weeks after end of last chemotherapy cycle. HIPEC with mitomycin C and cisplatin either at the time of CRS or a delayed HIPEC within 5-7 days.\n\nHIPEC:\n\nMitomycin C: 15 mg/m2 (max. 30 mg/ m2, max. 5 L Perfusion). Cisplatin: 75 mg/m2/L (max. 150 mg/m2, max. 5 L Perfusion). 4-12 weeks after cytoreductive surgery 3 cycles postoperative chemotherapy will be applied.\n\nPatients may get a HIPEC intervention without surgical cytoreduction if contraindication to the drugs can be excluded.\n\nIn case of therapy failure patients will be continued to be treated by the responsible investigator according to his medical status.","label":"With HIPEC","type":"EXPERIMENTAL"}],"collaborators":["German Cancer Aid"],"completion_date":{"date":"2021-06-09","type":"ACTUAL"},"conditions":["Malignant Neoplasm of Stomach","Secondary Malignant Neoplasm of Peritoneum","Secondary Malignant Neoplasm of Other and Unspecified Sites"],"enrollment":{"count":105,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"HIPEC","otherNames":[],"type":"PROCEDURE"}],"last_update":"2021-07-29","lead_sponsor":"Charite University, Berlin, Germany","official_title":"Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-10-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"The primary outcome measure is overall survival","timeFrame":"Death or 2.5 years"}],"references":[{"citation":"Rau B, Lang H, Koenigsrainer A, Gockel I, Rau HG, Seeliger H, Lerchenmueller C, Reim D, Wahba R, Angele M, Heeg S, Keck T, Weimann A, Topp S, Piso P, Brandl A, Schuele S, Jo P, Pratschke J, Wegel S, Rehders A, Moosmann N, Gaedcke J, Heinemann V, Trips E, Loeffler M, Schlag PM, Thuss-Patience P. Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial. J Clin Oncol. 2024 Jan 10;42(2):146-156. doi: 10.1200/JCO.22.02867. Epub 2023 Oct 31.","pmid":"37906724","type":"DERIVED"}],"start_date":{"date":"2014-03-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis","url":"https://clinicaltrials.gov/study/NCT02158988"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/gastripec-i-nct02158988"}